Centinel Spine has won FDA approval for two-level use of prodisc C Nova, its fourth-generation cervical total disc replacement, the company announced 14 October 2026. The approval completes a set: all three of Centinel's prodisc C cervical devices — Vivo, SK and now Nova — are approved for both one- and two-level replacement, a milestone the company calls its Match-the-Disc cervical portfolio. It lands three weeks after Centinel filed to go public on the NYSE.

Match-the-Disc in four numbers

3 of 3prodisc C cervical devices now approved for one- and two-level use
$157MCentinel's revenue for the 12 months ended 30 June 2026, per its IPO filing
42%worldwide prodisc revenue growth Centinel reported for the third quarter of 2025
$100Msize of the NYSE IPO Centinel filed for on 7 October 2026

Figures from Centinel Spine's SEC filings and its own announcements.

The last disc to catch up

Centinel Spine builds its cervical business on three distinct prodisc C implant designs, sold under what it calls the Match-the-Disc portfolio — the idea that surgeons can choose among differently shaped artificial discs to fit a patient's particular anatomy rather than fitting every patient to one design. prodisc C Vivo and prodisc C SK won FDA approval for two-level use in October 2025. prodisc C Nova, the newest and fourth-generation design in the line, had carried only a one-level approval since July 2022 — until the 14 October 2026 approval closed that gap.

Nova's design differs from its siblings in its tri-keel endplate layout, intended to anchor the implant across vertebral anatomy that a single-keel design might not fit as precisely. Its endplates are titanium alloy, which the company and outside device literature describe as reducing imaging artifact around the implant on follow-up MRI scans — a practical concern for spine patients who need repeat imaging. The design has been in clinical use in Europe since 2009; Centinel reported the first US implantation in October 2024, and the company says it remains available in the US on a limited-release basis.

“This approval represents another important advancement for our Match-the-Disc portfolio.” Steven Murray, Chief Executive Officer, Centinel Spine — 14 October 2026 announcement

Three designs, one acquired portfolio

Centinel Spine does not invent the prodisc design from scratch: the implant traces to Dr. Thierry Marnay's first French implantation in 1990, and Centinel acquired the worldwide prodisc total disc replacement assets, cervical and lumbar, from DePuy Synthes in a December 2017 deal financed with debt and equity backed by the Viscogliosi Brothers group. Centinel has built its newer cervical designs, SK and Nova, on top of that acquired platform, while continuing to sell the lumbar prodisc L system.

Three things the Match-the-Disc pitch rests on

A choice of three shapes

Vivo, SK and Nova differ in endplate and keel design; Centinel's pitch to surgeons is a matched-anatomy choice rather than a single implant fitted to every patient.

Titanium endplates, less MRI noise

Nova's titanium-alloy endplates are designed to reduce imaging artifact on follow-up MRI, a detail that matters for a population likely to need repeat spine imaging over decades.

A platform bought, then extended

Centinel built its current three-device cervical line on a 2017 acquisition of DePuy Synthes's prodisc assets, developing SK and Nova in-house afterward.

A two-company two-level club, three years running

Two-level cervical disc replacement has had few FDA-approved entrants: Zimmer Biomet's Mobi-C was the first device cleared for both one- and two-level use, and Medtronic's Prestige LP followed with its own two-level approval. Centinel's path has been different — three separate implant designs, approved for two-level use roughly a year apart from each other (Vivo and SK in October 2025, Nova in October 2026) — rather than one device winning the broader label outright. The approval arrives as Centinel pursues a public listing: the company's 7 October 2026 S-1 filing disclosed $157 million in revenue for the twelve months ended 30 June 2026, and it reported 42% worldwide prodisc revenue growth with record EBITDA in the third quarter of 2025.

A market two forecasters price differently

$7.8B → $12.1B

Global cervical disc replacement device market, 2030, as forecast by Zion Market Research (18.5% CAGR from a 2021 base) and Global Industry Analysts (18.3% CAGR from a 2024 base).

2021 (Zion base)$1.7B
2024 (GIA base)$4.4B
2030 (Zion)$7.8B
2030 (GIA)$12.1B

Sources: Zion Market Research, Cervical Total Disc Replacement Device Market (2030 forecast) · Global Industry Analysts, via GII Research (2030 forecast)

Regulatory News outlook

We expect the cervical disc replacement market to land closer to $9 billion than $12 billion by 2030, with a three-device two-level portfolio helping Centinel compete for share against Mobi-C and Prestige LP without yet displacing either as the category's default choice.

How we got here: We averaged the two 2030 forecasts cited above ($7.8 billion and $12.1 billion) to get roughly $10 billion, then shaded it down toward the lower, longer-tracked Zion estimate because the higher Global Industry Analysts figure uses a more recent, smaller 2024 base year compounded at a similar rate, which tends to produce a larger terminal number from the same growth assumption.

Three two-level cervical discs, one new to the group

ProductDesignEndplate materialTwo-level approvalMaker
prodisc C NovaTri-keel, flat endplatesTitanium alloyOctober 2026Centinel Spine
prodisc C Vivo / C SKSingle-keel variantsTitanium/cobalt-chromiumOctober 2025Centinel Spine
Mobi-CMobile-bearingCobalt chromium alloy, polyethyleneFirst device with original 2-level FDA approvalZimmer Biomet
Prestige LPBall-and-troughTitanium ceramic compositeFDA approved for 2-level useMedtronic

From each company's own labelling and announcements; not a clinical comparison.

From a 2017 acquisition to a planned listing

Centinel's cervical portfolio, step by step

  1. 2008

    Centinel Spine founded

    Established in West Chester, Pennsylvania, backed by the Viscogliosi Brothers investor group.

  2. December 2017

    prodisc portfolio acquired

    Centinel buys the worldwide prodisc total disc replacement assets, cervical and lumbar, from DePuy Synthes.

  3. July 2022

    One-level approvals for three cervical discs

    FDA approves prodisc C Vivo, C SK and C Nova for one-level cervical disc replacement.

  4. March 2020

    Steven Murray becomes CEO

    Murray, previously Worldwide President of Johnson & Johnson's Advanced Sterilization Products division, takes over as Centinel's chief executive.

  5. October 2025

    Two-level approvals for Vivo and SK

    FDA approves two-level use for prodisc C Vivo and prodisc C SK.

  6. 7 October 2026

    IPO filing

    Centinel Spine Holdco files a Form S-1 with the SEC to list on the NYSE as CNTL, seeking up to $100 million.

  7. 14 October 2026

    Two-level approval for prodisc C Nova

    FDA approval completes two-level clearance across all three prodisc C cervical designs.

  8. Ahead

    IPO pricing

    Centinel has not yet set a price range or listing date for its planned NYSE offering.

What the S-1 still leaves open

Centinel's own regulatory filing has not resolved every detail a reader might want: an earlier draft registration statement described only two of its three cervical discs as having two-level approval, while the company's most recent S-1 and this week's announcement describe all three. The exact PMA supplement number for prodisc C Nova's two-level approval had not been published in FDA's own database as of this story's publication, so it is not asserted here. Centinel has also not disclosed a price range, timing, or valuation target for its planned IPO.

  • IPO status: S-1 filed 7 October 2026 for up to $100 million on the NYSE as CNTL; no price range or date set yet.
  • Underwriters: Morgan Stanley, Goldman Sachs, Piper Sandler, Canaccord Genuity and BTIG are named as joint bookrunners.
  • PMA supplement number: not yet published by FDA for prodisc C Nova's two-level approval; this page will be updated when it is indexed.
  • Limited release: prodisc C Nova remains on limited US release, so its two-level approval does not necessarily mean immediate broad availability.

Sources & further reading

  1. Centinel Spine, “Centinel Spine® Receives FDA Approval for Two-Level Use of prodisc® C Nova, Further Expanding the Match-The-Disc™ Cervical Portfolio,” press release, 14 October 2026. prnewswire.com
  2. OrthoWorld, “Centinel Spine Gains FDA Approval for 2-Level prodisc C Nova,” 15 October 2026. orthoworld.com
  3. Medical Device Network, “Centinel Spine gets FDA nod for two-level use of prodisc C Nova,” 15 October 2026. medicaldevice-network.com
  4. Centinel Spine Holdco, Inc., Form S-1, U.S. Securities and Exchange Commission, filed 7 October 2026. sec.gov
  5. Renaissance Capital, “Spinal implant developer Centinel Spine files for a $100 million IPO,” 7 October 2026. renaissancecapital.com
  6. Zion Market Research, Cervical Total Disc Replacement Device Market (2030 forecast), via Becker's Spine Review. beckersspine.com

Regulatory News reports on public regulatory documents. It is not legal advice, and the primary sources above govern. If we have made an error, we will say so in public: see corrections.

Frequently asked questions

What did FDA approve?

Two-level use of Centinel Spine's prodisc C Nova cervical total disc replacement, announced 14 October 2026. Nova was already approved for one-level use since July 2022; the two-level approval completes the set for all three of the company's prodisc C cervical devices.

Which other Centinel discs already had two-level approval?

prodisc C Vivo and prodisc C SK received FDA approval for two-level use in October 2025. prodisc C Nova's two-level approval follows a year later.

Is Centinel Spine a public company?

Not yet. It filed a Form S-1 with the SEC on 7 October 2026 to list on the NYSE under the ticker CNTL, seeking to raise up to $100 million. No pricing terms had been set as of this story's publication.

Is prodisc C Nova widely available?

It is available in the US on a limited-release basis, the company says. It has been in clinical use outside the US since 2009.